EUCTR2010-023394-19-NL
Active, not recruiting
Phase 1
Early Beta blocker Administration before reperfusion in patients with ST-Elevation Myocardial Infarction who are planned to undergo primary PCI - Early-ßAMI
Maatschap Cardiologie Isala0 sites601 target enrollmentNovember 17, 2010
ConditionsPatients with acute ST elevation myocardial infarction, scheduled for emergency coronary angioplastyMedDRA version: 18.0Level: LLTClassification code 10066641Term: Acute myocardial infarction, of anterior wallSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Drugsmetoprolol tartraat
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with acute ST elevation myocardial infarction, scheduled for emergency coronary angioplasty
- Sponsor
- Maatschap Cardiologie Isala
- Enrollment
- 601
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients \= 18 years of age with symptoms of acute ST\-elevation myocardial infarction of more than 30 min but less than 12 hours and on the ECG ST\-segment elevation of \>\= 0\.1 mV in two adjacent limb electrocardiograph (ECG) leads and \>\= 0\.2 mV in two adjacent precordial ECG leads or new left bundle branch block (LBBB).
- •Verbal followed by written informed consents.
- •PCI\-center located within 90 minutes
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 301
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 300
Exclusion Criteria
- •Severe Hypotension (systolic blood pressure \< 100 mmHg)
- •Cardiogenic shock (severe dyspnoea, hypotension and oxygen saturation \<92%, systolic blood pressure \< 100 mmHg and heartrate \> 110/min)
- •Known with asthma
- •Severe bradycardia at sinusrythm (\< 60 bpm)
- •PR interval \>240 ms or second\- and/or third degree atrio\-ventricular (AV) block
- •History of previous myocardial infarction
- •Killip class III\-IV
- •Pacemaker/implantable cardioverter defibrillator (ICD)
- •Unable to provide informed consent
- •Patient is pregnant or breastfeeding
Outcomes
Primary Outcomes
Not specified
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